Stage IIIB Prostate Cancer AJCC v8 Clinical Trial
Official title:
A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
Verified date | December 2023 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2029 |
Est. primary completion date | November 2028 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ability to understand and willingness to sign an informed consent form - Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment - Eastern Cooperative Oncology Group (ECOG) performance status = 1 (Karnofsky = 70%) - Patients = 18 years of age at time of consent - Life expectancy = 5 years - Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study Exclusion Criteria: - Nodal or distant metastases - Prior treatment for prostate cancer - Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery = 6 months prior to focal therapy in this study - Known contraindications to general anesthesia - Uncorrectable coagulopathy - Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction - Any condition that would prohibit the understanding or rendering of informed consent - Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Marc Dall'Era, MD | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic outcome on surveillance prostate biopsy | Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression. | At year 1 and 3 | |
Primary | Proportion of participants who go onto whole gland salvage treatment | Will be estimated using the Kaplan-Meier method. | At 3 years | |
Primary | Salvage whole gland treatment free survival | Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models. | At 3 years | |
Secondary | Urinary function | Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function. | At 1 year | |
Secondary | Sexual function | Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function. | At 1 year | |
Secondary | Quality of life | Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life. | At 1 year | |
Secondary | Adverse events | Number of participants experiencing treatment-related AEs, classified by severity and grade. | Up to end of treatment visit, approximately 7-14 days after treatment |
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